SYNERGY™ XD H7493941816450Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729981190), received between Apr 27, 2021 and Dec 13, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 4.50 X 16MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. HOWEVER, DURING ADVANCING, THE DELIVERY SYSTEM WAS FRACTURED INTO 2 PIECES AFTER FORCEDLY PUSHING IT INTO THE LESION. THE DEVICE WAS COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A 4.0X16 SYNERGY DES. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319434 ↗
• MalfunctionFeb 4, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DIFFICULTY REMOVAL, SHAFT BREAK, AND PROCEDURE RESCHEDULING OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED HOWEVER THEY MET RESISTANCE IN THE VESSEL RIGHT AS THE STENT EXITED THE GUIDE CATHETER. THEY PUSHED AND PULLED AND NOTICE THE HYPOTUBE CAME OUT WITHOUT THE DISTAL PART OF THE DELIVERY SYSTEM. THEY BROUGHT THE WHOLE SYSTEM OUT AND WAS ABLE TO RETRIEVE THE BROKEN PART OF THE SHAFT. SUBSEQUENTLY, A 4.50 X 16MM SYNERGY XD WAS ADVANCED BUT MET THE SAME RESISTANCE, THIS TIME THE SHAFT BENT BUT DIDN'T BREAK. THEY TRIED ONE MORE BALLOON AND IT DIDN'T CROSS SO THEY STOPPED THE PROCEDURE AND SENT THE PATIENT TO SURGERY. NO PATIENT ISSUES BECAUSE OF THE STENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13450384 ↗
• MalfunctionApr 27, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 4.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, AFTER DEPLOYING THE STENT, THE FULLY DEFLATED BALLOON WAS DIFFICULT TO WITHDRAW FROM THE STENT. THE BALLOON WAS REMOVED BY PULLING BACK ON CATHETER SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735655 ↗